Infections with pathogens are commonly observed all over the world. Such infections include viral, bacterial, fungal and parasite infections. Early diagnosis of an infection is often preferred for efficient treatment, which can prevent severe pathological symptoms. Sometimes, early diagnosis is a prerequisite for a possibility of treatment, for extending a lifetime and/or for improving the quality of life. Examples of such infections comprise Hepatitis C virus, Hepatitis B virus, tuberculosis, malaria and HIV, such as HIV-1.
The HIV-1 epidemic spreads readily over the world and with the spread of the virus, the circulating subtypes of the HIV-1 virus are no longer restricted to one geographical place on earth. This development requires an application of (nucleic acid) diagnostic tests that can detect all subtypes of the HIV virus with equal accuracy and precision.
The globalization of the epidemic and, especially, the severity in resource-poor countries (sub-Saharan Africa and south-east Asia) has driven the developed world to assist the fighting of infection in the less-developed countries with access programs to pharmaceuticals. However, in order to efficiently help HIV-1 infected people in the less-developed world, there has to be suitable diagnostics in place to monitor the efficacy of a treatment. Such suitable diagnostics are especially viral load assays that measure the amount of HIV-1 RNA in a bodily fluid, such as blood, blood plasma, mother's milk, semen, lymph fluid, sputum, liquor, saliva and/or urine of infected individuals. Likewise, suitable nucleic acid load assays are desired for other infection-related diseases.
The current status of suitable nucleic acid load assays is of such a high technical standard that these are not easily transferred to areas located at considerable distance of technological resources such as in sub-Saharan Africa and/or south-east Asia. This requires significant investment in infrastructure that is impossible in the setting of these regions. An alternative solution is an analysis of patient samples in laboratories in the developed world (for instance Europe and north America). This alternative is, however, impossible to exercise due to logistic problems. Body fluid samples such as blood or blood plasma samples of individuals have to be shipped to the laboratory in frozen conditions at temperatures well below 0° C., usually in a box with dry ice. This way of sending clinical material is very expensive and requires the availability of dry ice at the place of shipment. The latter is often not the case in countries of the less-developed world. Because of the costs and the unavailability of dry ice the remote testing of samples in laboratories (“service testing”) is not an option for these countries and for infected people in these countries. The pharmaceutical access programs for less-developed countries can only be successful if diagnosis is optimized.